Of the 24 million patients diagnosed with diabetes in the US, 6.5 million (27%) depend on a strict regime of insulin administration. Limited or unreliable patient reporting of critical diabetes care parameters (blood glucose measurements, carbohydrate intake, and insulin regime) is the leading source of diabetes mismanagement contributing to the $174 billion/year spending in diabetes care in the US. In particular, inaccurat insulin bolus computation in combination with limited tracking of critical diabetes care parameters is recognized as a principal cause of recurrent hypoglycemic events leading to poor diabetes management outcomes in insulin dependent patients. Despite the reported benefits of insulin pumps equipped to calculate insulin bolus and track diabetes care parameters, only 375,000 insulin dependent patients use them, leaving the majority of 6.1 million Americans in need of a solution. KRIKORJAN proposes Personal Mobile Diabetes Management System: IN-TRACK to deliver clinically accurate computation support and monitoring of critical diabetes care parameters leading to enhanced insulin management treatment. Phase I will focus in the development of IN-TRACK, an Insulin Management tool that incorporates a real-time insulin bolus computation with history tracking of diabetes care parameters, remaining active insulin, and physical activity, supporting the patient and the healthcare team in effectively managing insulin treatment and, by extension, diabetes. This Phase I development involves two Aims.
Aim 1 will focus on building of a mobile software program capable of computing the next suggested insulin bolus (SIB) and tracking blood glucose, carbohydrate intake, physical activity, and remaining active insulin, and insulin in real-time as well as historically. The accuracy of SIB computation will be validated during Aim 2 via comparison testing against current insulin computation methods: insulin pumps (Revel(R) (MiniMed), Animas(R) (Johnson &Johnson), and OmniPod(R) (Insulet), electronic computations (the iPhone InsulinCalculator" (Friday Forward), the FreeStyle(R) InsuLinx (Abbott)) and paper protocols (paper wheel InsuCalc" (InsuCalc.com)). In Phase II, a clinical trial will evaluate the IN- TRACK potential to prevent insulin "stacking" (several boluses given in a short period of time leading to overlapping insulin activity) and associated reduction in hypoglycemic events. Additional tracking and just-in- time support and persuasion capabilities will be incorporated to address patient and clinical team needs emerging from the clinical evaluation. IN-TRACK builds on the patient and clinical need for practical and cost-effective tools to improve insulin management. Its practicability is embodied by the familiar mobile framework onto which is built requiring limited training and alleviating pump related limitations, while its usefulness is reflected by limiting hypoglycemic events and their life-threatening complications.

Public Health Relevance

IN-TRACK addresses the needs of 94% of the insulin dependent diabetic population by offering a practical and cost-effective solution to improved diabetes treatment through better Insulin Management. Its clinically accurate insulin dose calculator is enhanced by real-time monitoring of blood glucose measurements, carbohydrate intake, physical activity, and insulin regime, along with quick access to trends by patient as well as clinician, followed by appropriate feedback. IN-TRACK represents a powerful Insulin Management tool which is expected to significantly reduce hypoglycemic incidents and improve overall diabetes care.

Agency
National Institute of Health (NIH)
Institute
National Center for Advancing Translational Sciences (NCATS)
Type
Small Business Innovation Research Grants (SBIR) - Phase I (R43)
Project #
1R43TR000570-01A1
Application #
8311248
Study Section
Special Emphasis Panel (ZRG1-EMNR-E (10))
Program Officer
Filart, Rosemarie
Project Start
2012-08-03
Project End
2013-07-31
Budget Start
2012-08-03
Budget End
2013-07-31
Support Year
1
Fiscal Year
2012
Total Cost
$244,226
Indirect Cost
Name
Krikorjan, Inc.
Department
Type
DUNS #
965479988
City
Menlo Park
State
CA
Country
United States
Zip Code
94025